CBER Unveils Slender Guidance Agenda for 2022

The FDA’s Center for Biologics Evaluation and Research (CBER) has released its guidance agenda for 2022, listing just 13 draft and final guidances the center intends to issue this year.

The center plans to issue a revised draft guidance covering Emergency Use Authorizations for COVID-19 vaccines.

Other planned publications include a final guidance on gene therapies for neurodegenerative diseases, a draft guidance on gene therapies using genome editing technology and a draft guidance on development considerations for chimeric antigen receptor (CAR)-T cell therapies.

CBER said it may also develop other guidance documents on topics not on the list.

Read the full list here: www.fdanews.com/01-27-22-CBERGuidanceAgenda.pdf.